EP1624914B1 - Interne nadeleinführvorrichtung - Google Patents

Interne nadeleinführvorrichtung Download PDF

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Publication number
EP1624914B1
EP1624914B1 EP04731882A EP04731882A EP1624914B1 EP 1624914 B1 EP1624914 B1 EP 1624914B1 EP 04731882 A EP04731882 A EP 04731882A EP 04731882 A EP04731882 A EP 04731882A EP 1624914 B1 EP1624914 B1 EP 1624914B1
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EP
European Patent Office
Prior art keywords
needle
medical device
actuation
spring
movement
Prior art date
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Revoked
Application number
EP04731882A
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English (en)
French (fr)
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EP1624914A1 (de
Inventor
Erik Winkel Ethelfeld
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Novo Nordisk AS
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Novo Nordisk AS
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Publication date
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581—Right-angle needle-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the present invention generally relates to the insertion of transcutaneous devices such as needles, needle-like members and cannulas. More specifically, the invention relates to insertion of a transcutaneous device at a selected site within the body of a subject for subcutaneous, intravenous, intramuscular or intradermal delivery of a drug to the subject, the transcutaneous device being carried by a device comprising a mounting surface adapted for application to the skin of the subject. Especially, the invention relates to insertion of an infusion needle or cannula for the infusion of a drug, to insertion of a needle-formed sensor, as well as to insertion of insertion needles for easy placement of a device such as a sensor through the skin of a subject.
  • Portable drug delivery devices for delivering a drug to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug and having an outlet in fluid communication with a hollow infusion needle, as well as expelling means for expelling a drug out of the reservoir and through the skin of the subject via the hollow needle.
  • Such devices are often termed infusion pumps.
  • infusion pumps can be divided into two classes.
  • the first class comprises durable infusion pumps which are relatively expensive pumps intended for 3-4 years use, for which reason the initial cost for such a pump often is a barrier to this type of therapy.
  • the pump offer the advantages of continuous infusion of insulin, precision in dosing and optionally programmable delivery profiles and user actuated bolus infusions in connections with meals.
  • the disposable pumps generally comprises a skin-contacting mounting surface adapted for application to the skin of a subject by adhesive means, and with the infusion needle arranged such that in a situation of use it projects from the mounting surface to thereby penetrate the skin of the subject, whereby the place where the needle penetrates the skin is covered while the appliance is in use.
  • the infusion needle may be arranged to permanently project from the mounting surface such that the needle is inserted simultaneously with the application of the infusion pump. Examples of this configuration can be found in US patents 2,605,765 , 4,340,048 and in EP 1 177 802 . Although this configuration provides a simple and cost-effective solution, the actual user-performed piercing of the tissue with the needle is often problematic as people who are not experts in medicine are usually insufficiently practised to place such a needle correctly and they often suffer from a fear of the likely pain.
  • US patent 5,851,197 discloses an injector in which an infusion set comprising a skin-mountable surface with a protruding needle can be mounted, the injector upon actuation driving the entire infusion set into contact with a skin portion whereby the needle is inserted through the skin.
  • infusion pump devices have been proposed in which the pump device is supplied to the user with the needle in a retracted state, i.e. with the distal pointed end of the needle "hidden” inside the pump device, this allowing the user to place the pump device on the skin without the possibility of observing the needle.
  • the needle is hidden, at least some of the fear is overcome making the introduction of the needle in a second step less problematic.
  • US patents 5,858,001 and 5,814,020 disclose infusion devices of this type in which an infusion needle is arranged in an upper housing portion pivotably arranged relative to a base plate portion. In this way the user can introduce the needle by pressing the upper portion into engagement with the base plate portion.
  • US patent 5,957,895 discloses a liquid drug delivery device comprising a bent injection needle which is adapted to project through a needle aperture in the bottom surface of the housing in a situation of use.
  • a movable needle carrier is disposed in the housing for carrying the injection needle and for causing the injection end of the needle to project through the needle aperture upon movement of the needle carrier.
  • US patent 5,931,814 discloses an infusion device having a housing with a drug reservoir, an infusion needle (or cannula) communicating with the reservoir, means for inserting the needle, and pump means for discharging the reservoir contents through the needle.
  • the needle is fixed relative to the housing and projects beyond the lower skin-contacting surface of the housing to the depth required for injection.
  • the needle is surrounded by a protective element which is moved by spring means from a first end position in which the protective device projects beyond the lower surface of the housing and beyond the needle to a second end position in which the protective device does not project beyond the underside of the casing.
  • An advantage of this design is that the needle is arranged in a fixed position relative to the reservoir.
  • WO 02/15965 discloses a similar infusion device in which a base plate member acts as a protecting element until an upper part of the device, to which the needle is fixed, is moved down into engagement with the base plate member.
  • the needle is automatically inserted by the release of pre-tensioned spring means arranged within the devices, whereas in the device known from WO 02/15965 the needle is inserted by the user actively moving the hidden needle.
  • the automatic needle insertion means adds convenience for the user and may serve to overcome needle fear, such means also adds to the complexity and thus to the cost of the device, just as they may reduce the reliability.
  • drug infusion pumps either disposable or durable, may provide convenience of use and improved treatment control
  • a given monitor system for measuring the concentration of a given substance may be based on invasive or non-invasive measuring principles.
  • An example of the latter would be a non-invasive glucose monitor arranged on the skin surface of a patient and using near-IR spectroscopy, however, the present invention is concerned with the introduction of a transcutaneous device such as a needle-formed sensor element.
  • the sensor may be placed subcutaneously being connected to external equipment by wiring or the substance (e.g. fluid) to be analysed may be transported to an external sensor element, both arrangements requiring the placement of a subcutaneous component (e.g. small catheter or tubing), the present invention addressing both arrangements.
  • a subcutaneous component e.g. small catheter or tubing
  • the term "sensor” is used in the following for both types of elements introduced into the subject.
  • US patent 5,954,643 discloses an insertion set comprising a mounting base supporting a proximal end of a flexible thin film sensor, the sensor including a distal segment with sensor electrodes thereon which protrudes from the mounting base for transcutaneous placement, wherein the sensor distal segment is slidably carried by a slotted insertion needle fitted through the assembled base. Placement of the insertion set against the patient's skin causes the insertion needle to pierce the skin to carry the sensor electrodes to the desired subcutaneous site, after which the insertion needle can be slidably withdrawn from the insertion set.
  • a similar arrangement is known from US patent 5,568,806 .
  • EP-A-937 475 An injection device with the features of the preamble of claim 1 is disclosed in EP-A-937 475 .
  • a device comprising a transcutaneous device and insertion means (or driving means) therefore, which allows for easy and swift, automatic insertion of the transcutaneous device, yet is reliable in use.
  • the device should be compact in size and be designed for cost effective manufacturing.
  • the transcutaneous device insertion means can be activated by the user during actuation of the insertion means for the transcutaneous device.
  • activation of the insertion means relates to the energizing thereof
  • actuation relates to the user-related input responsible for both energizing and release of the insertion means.
  • a medical device comprising a housing having a mounting surface adapted for application to the skin of a subject, a transcutaneous device with a distal, pointed end portion adapted to penetrate the skin of the subject, wherein the transcutaneous device has a first position in which the distal end portion is retracted within the housing, and a second position in which the distal end portion projects relative to the mounting surface.
  • the medical device further comprises actuatable driving means disposed within the housing and adapted to move the transcutaneous device from the first position to the second position when the driving means is actuated, wherein the driving means is actuatable from a first state through an intermediate state to a second state, whereby actuation of the driving means from the first to the intermediate state causes activation of the driving means, and actuation of the driving means from the intermediate to the second state causes release of the activated driving means thereby moving the transcutaneous device from the first position to the second position.
  • the first state may also be termed an initial state just as the second state may be termed an active state.
  • the activated state not necessarily is a stable state in which the spring means can be left, but a state which may require that an actuation input (e.g. a force applied by the user) is upheld, i.e. the spring means may resume an initial state if the actuation input is removed. Further, the actuation means may be partly energized in their initial state.
  • an actuation input e.g. a force applied by the user
  • a medical device which can be supplied to the user in a non-energized or only slightly energized state, the energizing taking place when the device is actuated by the user which means that energy will be stored only for a period from a few seconds to a few hours or days.
  • the device may be designed such that the drive means is fully depleted from energy when the transcutaneous device has been inserted (e.g. by locking the transcutaneous device in its second position), or it may be designed to exert a biasing force upon the transcutaneous device in its second position.
  • the drive means and the elements upon which a force is exerted by the drive means can be optimized for a very short "active" life, this in contrast to arrangements in which energy is stored corresponding to the entire shelf life of the device, e.g. one or more years.
  • energy is stored corresponding to the entire shelf life of the device, e.g. one or more years.
  • much higher requirements would have to be fulfilled for a polymer spring adapted for storing energy during a period of several years, or by a polymer structure adapted for locking a metal spring during a corresponding period.
  • to prevent structures from locking (e.g. "growing together") during storage it may be necessary to store additional energy to overcome a possible locking resistance, this adding to the aforementioned problems.
  • by providing a device which can be shipped, stored and handled in a non-energized condition the risk of accidental actuation will be reduced.
  • the transcutaneous device may be in the form of a pointed hollow infusion needle, a micro needle array, a pointed needle sensor, or a combination of a relatively flexible per se blunt cannula or sensor device with a pointed insertion needle may provide a pointed transcutaneous device, the insertion needle being retractable after insertion of the blunt portion of the transcutaneous device.
  • the cannula is advantageously soft and flexible relative to the insertion needle which typically is a solid steel needle.
  • the driving means comprises spring means adapted for releasably storing energy which can be activated respectively released when the driving means is actuated from the first state through the intermediate state to the second state by the user.
  • the spring means may comprise any elastically compressible or deformable means, e.g. a metal or polymer member, an elastomeric foam or a gas.
  • the driving means may be arranged to exert a force on at least a portion (e.g. in case the device comprises a retractable insertion needle) of the transcutaneous device in the second state thereby biasing it towards the second position.
  • the mounting surface comprises an aperture formed therein, the distal end portion of the transcutaneous device being moved through the aperture when the transcutaneous device is moved from the first to the second position.
  • the transcutaneous device may be provided as part of a unit (e.g. a needle unit) which is then engaged and moved by the driving means.
  • the spring means comprises a drive portion adapted to engage an engagement portion of the transcutaneous device (i.e. the engagement portion may be part of the transcutaneous device or it may be associated therewith, e.g. by means of the aforementioned unit) when the spring means is released (e.g. the two portions actually coming into engagement with each other), wherein activation of the spring means causes an activation movement of the drive portion corresponding to the movement by which energy is releasably stored in the spring means, and a displacement movement, different from the activation movement, in which the drive portion and the engagement portion are moved relative to each other.
  • the spring means when the user activates the spring means two actions take place: The spring is stressed and positioned relative to the portion of the needle unit which it is adapted to engage when released. The positioning may take place by moving the spring means, the needle unit or both.
  • the spring means will directly engage the needle or the structure carrying the needle, however, the needle unit may be provided with transfer or linkage means allowing the spring means to act indirectly on the needle, e.g. when it is desirable to transform a primary movement of the spring means such as from an upwards to a downwards movement.
  • the transcutaneous device may be introduced subcutaneously at any desired angel relative to the mounting surface (and thus the skin surface), e.g. in the second position the distal end portion may extend generally perpendicular to the mounting surface.
  • the drive portion corresponding to the first state may be arranged below and beside the engagement portion (with respect to the mounting surface), and such that the drive portion corresponding to the intermediate state is arranged in an upper position substantially above the engagement portion.
  • the device advantageously comprises actuation means moveable from a first position through an intermediate position to a second position, whereby movement of the actuation means from the first to the intermediate position causes activation of the spring means, and movement from the intermediate to the second position causes release of the activated spring means thereby moving the needle from the first position to the second position.
  • the actuation means may be in the form of user actuatable element which can be gripped or moved by the user relative to the housing (e.g. a button), or a (major) portion of the housing may be moveable relative to a base portion comprising the mounting surface.
  • the movement preferably corresponds to a substantially non-composite movement (e.g. a unidirectional linear or rotational movement which may be with or without an intermediate lockable state).
  • actuation of the actuation means from the first through the intermediate to the second condition is accomplished by moving two actuation elements against each.
  • the spring means is coupled to the actuation means, whereby the displacement movement of the drive portion substantially corresponds to the movement of the actuation means from the first to the intermediate position.
  • the device comprises ramp (or lifting) means adapted to engage the spring means, such that movement of the actuation means from the first to the intermediate position causes the ramp means to move (lift) the drive portion to its upper position, and movement of the actuation means from the intermediate position to the second position causes the ramp means to disengage and thereby release the spring means.
  • the spring means may comprise a spring member (e.g. a "physical” member such as a leaf spring or a "piano" string, this in contrast to a gas spring) having a proximal end mounted to the actuation means and a distal deflectable end portion comprising the drive portion, the distal end portion engaging the ramp means.
  • the needle unit comprises a needle carrier carrying the needle, the needle carrier being coupled (e.g. pivotally) to the housing for controlled movement of the needle between the first and second positions.
  • the first unit comprises a transcutaneous device comprising a transcutaneous member (e.g. a soft cannula or a sensor) in combination with a co-axially or co-linearly arranged pointed insertion needle, the insertion needle and the transcutaneous member being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated, wherein the insertion needle is arranged to be moveable away from the distal end of the transcutaneous member when the cannula and the insertion needle have been moved to their second position.
  • Advantageously spring means is provided for automatically moving the insertion needle when the combined transcutaneous device has been advanced to the second position.
  • the present invention may be utilized in combination with a number of different types of devices.
  • the needle may be in the form of a hollow infusion needle, the first unit further comprising a reservoir adapted to contain a liquid drug and comprising in a situation of use an outlet in fluid communication with the infusion needle, as well as expelling means for expelling a drug out of the reservoir and through the skin of the subject via the hollow needle.
  • the reservoir and the expelling means may be of any suitable type, e.g. of any of the types described in the above-referred documents.
  • the reservoir may be connected to the actuation means, and arranged such that movement of the actuation means between the first and the second position causes the reservoir to be arranged in fluid communication with the infusion needle.
  • movement of the actuation means between the first and the second position causes actuation of the expelling means.
  • the needle may also be in the form of a needle sensor comprising sensor means capable of being influenced by a body substance and producing a signal corresponding thereto.
  • the sensor means may be of any suitable type, e.g. of any of the types described in the above-referred documents.
  • the first unit comprises an additional needle-formed member having a distal end, the needle-formed member having a first retracted position relative to the second unit, and a second position in which the distal end projects relative to the second unit, wherein the needle is in the form of a removable insertion needle arranged co-axially with and supporting the needle-formed member, the insertion needle and the needle-formed member being arranged to be simultaneously moved by the driving means from their respective first position to their respective second position when the driving means is actuated.
  • the insertion needle may be fixed or moveable relative to the mounting surface.
  • the insertion needle may have any desirable configuration such as solid or grooved.
  • the mounting surface advantageously comprises adhesive means for adhering the first unit to the skin of the subject.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • subcutaneous infusion is meant to encompass any method in which a needle device is inserted at a selected site within the body of a patient for subcutaneous, intravenous, intramuscular or intradermal delivery of a drug to a subject.
  • needle or needle device defines a piercing member (including an array of micro needles) adapted to be introduced into or through the skin of a subject.
  • FIGs. 1-3 show in schematic representations perspective views of different states of use of a medical device in accordance with the invention.
  • the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
  • fig. 1A shows a first embodiment of a medical device 100 gripped by a user.
  • the medical device comprises a housing with an upper housing portion 110 and a lower base plate portion 120, the housing providing a cavity in which an actuation member 130 is slidingly received through an opening, the actuation element being moveable corresponding to a longitudinal direction in respect of the device.
  • the base plate portion comprises an adhesive mounting surface 121 adapted for application to the skin of a subject, the mounting surface being generally planar and defining a general plane.
  • the actuation member comprises a ribbed area allowing for easy gripping by a user, e.g. using the first and second fingers as shown.
  • the actuation member is formed as a frame having opposed side portions 131, 132 adapted to be in sliding engagement with inner surface portions of the upper housing portions, the inner surface portions comprising longitudinally ridges received in corresponding grooves formed on the outer surfaces of the side portions.
  • the two side portions are connected by a button portion 135 corresponding to an outer end and by a bridge portion 136 corresponding to an inner end thereof, the bridge portion comprising a spring means in the form of a leaf spring 137 having a free end portion with an inclined orientation relative to the base plate portion, the leaf spring serving as an insertion spring.
  • the leaf spring may be attached to the bridge portion (e.g. when made from a metal alloy) or it may be formed integrally with the actuation member (e.g.
  • the base plate portion comprises an upper surface on which a female hinge member 138 and a ramp member 139 are formed, preferably formed integrally with the base plate portion.
  • the ramp member comprises an upper inclined ramp surface 147 adapted to engage a lower surface of the leaf spring 137 (serving as a drive portion adapted to engage a corresponding engagement portion on the transcutaneous device), the ramp surface terminating in an upper free edge 148.
  • the term "ramp" also covers the embodiment in which a narrow upstanding wall terminates in a free edge over which the leaf spring slides.
  • the device further comprises a transcutaneous device in the form of an infusion needle forming part of a needle unit 150 connected to the base plate portion by a hinge allowing the needle unit to pivot corresponding to a pivoting axis defined by the hinge, the pivoting axis being arranged substantially in parallel with the mounting surface.
  • the needle unit comprises a hollow infusion needle (see fig. 7 ) having a distal pointed outlet portion 151 adapted to penetrate the skin of the subject, the outlet portion extending generally perpendicular to the mounting surface, and a pointed proximal inlet portion 152 arranged substantially corresponding to the pivoting axis.
  • the distal end may be straight or curved, e.g. arcuate corresponding to the pivoting axis.
  • the needle is carried by a needle carrier comprising an arm portion 153 and a cylindrical male hinge portion, the needle carrier being connected to the female hinge member thereby forming the hinge.
  • the arm comprises a biasing member in the form of a leaf spring 155 projecting therefrom, the spring being in engagement with the upper surface of the base plate member thereby providing an upwardly directed biasing force forcing the needle into its initial position.
  • the needle unit can pivot between an initial position in which the inlet portion of the needle is retracted within the housing, and a second position in which the inlet portion projects relative to the mounting surface through an opening (not to be seen in the figs.) formed in the base plate portion.
  • the hinge is provided by cooperating members of the needle carrier respectively the housing, however, a "naked" needle may be connected to the housing or the needle carrier and the housing may be formed integrally connected to each other by a film-hinge.
  • the device further comprises a reservoir 160 adapted to contain a liquid drug and comprising in a situation of use an outlet in fluid communication with the infusion needle, and expelling means (not shown for better illustrating the principles of the invention) for expelling a drug out of the reservoir and through the skin of the subject via the hollow needle.
  • the reservoir and the expelling means are mounted on the actuation member and thus moveable relative to the housing.
  • the reservoir comprises a needle-penetratable septum 161 adapted to cooperate with the inlet portion of the infusion needle, the septum being arranged substantially corresponding to the pivoting axis, thereby allowing the needle unit to pivot substantially without non-rotational displacement of the inlet portion of the infusion needle relative to the septum.
  • the user presses the actuation member 130 into the housing whereby the needle is inserted and the delivery means started.
  • the actuation member is moved from a first (initial) position through an intermediate position to a second position.
  • the insertion spring 137 is moved relative to the ramp member, this causing an upwards activation movement of the drive portion whereby energy is releasably stored in the spring, and a displacement movement in which the drive portion is moved to a position above the engagement portion of the needle unit.
  • the reservoir is moved into fluid communication with the infusion needle.
  • actuation of the actuation member from the intermediate to the second position causes release of the activated spring (when the distal free edge of the insertion spring slides over the upper free edge of the ramp, whereby the insertion spring in a snap-action engages the needle unit thereby biasing it downwardly to its second position against the force of the biasing spring 155.
  • the actuation member is locked in place by the insertion spring being locked behind the ramp member.
  • the delivery means or sensor electronics will have to be actuated in combination with insertion of the needle, either in combination with the above-described actuation of the needle (e.g. by closing an electric contact or by providing a fluid communication) or by using additional actuation means which may be operated separately after the device has been mounted on the skin and the needle introduced.
  • a second embodiment of a medical device 200 similar to the first embodiment, the device comprising an upper housing portion 210 and a lower base plate portion 220, the housing providing a cavity in which an actuation member 230 is slidingly received through an opening, the actuation element being moveable corresponding to a longitudinal direction.
  • the device further comprises a reservoir 260 and a transcutaneous device in the form of an infusion needle forming part of a needle unit 250.
  • the device also comprises an inserter spring 237 and a ramp member 247, however, in contrast to the first embodiment the inserter spring is in the form of a thin rod (or string) just as the ramp member is arranged to deflect the inserter spring upwards as well as sidewards.
  • the ramp surface is somewhat longer and has a concave cross-sectional configuration, this allowing the rod spring to slide thereon without accidental disengagement.
  • the ramp terminates in an obliquely oriented deflection wall 249 which will force the spring rod outwards when forced thereagainst.
  • the rod may be formed integrally with the actuation member or attached as a separate member, e.g. as a metal string.
  • the needle unit is similar to the first embodiment apart from comprising a separately formed engagement portion 257 projecting from the distal end of the carrier arm and arranged on the side of the ramp member just below the deflection wall. Further, in contrast to the first embodiment, the actuation member does not comprise a bridge portion connecting the inner ends of the side portions.
  • the second embodiment is actuated in the same way as the first embodiment, the primary difference being that the insertion spring is released from the upper ramp surface by a sidewards movement provided by the deflection wall.
  • actuation member has been moved linearly, however, other movements may be utilized in accordance with the invention.
  • a medical device may have a circular configuration in which actuation may be provided by the user rotating an upper portion of the housing.
  • the insertion spring may extend radially with a free peripheral end sliding on a curved ramp.
  • Fig. 7A shows a needle unit 150 adapted to be connected to a housing member by a hinge allowing the needle unit to pivot corresponding to a pivoting axis defined by the hinge.
  • the needle unit comprises a needle carrier having a cylindrical hinge portion 154 defining the pivoting axis, and an arm member 153 extending perpendicularly from the hinge portion in respect of the pivoting axis.
  • a biasing means is arranged in the form of a leaf spring member 155 adapted to engage a portion of the housing.
  • the needle carrier carries a needle having a distal pointed portion 151 adapted to penetrate the skin of the subject, the distal portion extending generally perpendicular to the mounting surface, and a proximal portion (152) arranged substantially corresponding to the pivoting axis.
  • the needle unit can be arranged to pivot between a first position in which the distal portion of the needle is retracted within a housing, and a second position in which the inlet portion projects relative to a mounting surface.
  • the arm member may be provided with a needle-penetratable septum 159 allowing an insertion needle to be inserted through the cannula as shown in fig. 9A .
  • the carrier may be injection moulded around a needle, however, the carrier may also be formed from sheet metal to which a needle is attached e.g. by adhesive or welding.
  • the transcutaneous device has been in the form of a unitary needle device (e.g. an infusion needle as shown or a needle sensor (not shown)), however, the transcutaneous device may also be in the form of a combination of cannula or a sensor in combination with an insertion needle which is withdrawn after insertion thereof.
  • a unitary needle device e.g. an infusion needle as shown or a needle sensor (not shown)
  • the transcutaneous device may also be in the form of a combination of cannula or a sensor in combination with an insertion needle which is withdrawn after insertion thereof.
  • figs. 9A-9C show in a schematic representation how a cannula and insertion needle combination can be implemented in a device 300 (partly shown) of the type described with reference to figs. 4-6 .
  • a transcutaneous device unit 350 of the type shown in fig. 7 is provided, however, in contrast to the needle unit 150 the transcutaneous device unit comprises a combination of a relatively soft cannula 351 (which e.g. may be of the soft "Teflon®" type) carried by a lower arm portion 353 and a pointed insertion needle 361 (e.g.
  • the lower arm further comprises a seal member 352 through which the insertion needle is arranged.
  • the cannula and the insertion needle may be straight or curved, e.g. arcuate corresponding to the pivoting axis.
  • the two arms comprise mating coupling means 367, 357 locking the arms together in an initial position with distal end of the insertion needle extending from the distal opening of the cannula as shown in fig. 9A .
  • the cannula is provided with locking means adapted to engage a base plate 320 of the device when the cannula has been moved to an extended position through an aperture 323 in the base plate.
  • locking means adapted to engage a base plate 320 of the device when the cannula has been moved to an extended position through an aperture 323 in the base plate.
  • a spring member 368 is arranged biasing the flexible arm upwards.
  • the device also comprises an inserter spring 337 and a ramp member 347, as well as an additional coupling release member 348.
  • the inserter spring is energized by being moved up the ramp by the user and then released to engage the lower arm to thereby pivot the transcutaneous device unit towards the extended position as shown in fig. 9B .
  • the locking means of the cannula engages the housing of the device (here: an opening in the lower surface) and the coupling release member 348 engages the arm coupling means to thereby release the upper arm from the lower arm whereby the upper arm is moved towards its initial position by the spring member 368, thereby withdrawing the insertion needle from the cannula, see fig. 9C .
  • the cannula is irreversibly locked to the housing, however, advantageously releasable locking means is provided between the lower arm (or cannula) and the housing, this allowing the cannula to be withdrawn from its extended position before or after the used device is removed from the skin portion to which it has been attached, e.g. as illustrated in fig. 10A .
  • figs. 10A-10D an alternative embodiment of a cannula and insertion needle arrangement is provided. More specifically, fig. 10A shows in a schematic representation how a cannula and insertion needle combination can be implemented in a device having the same user functionality as the above-described devices but realized with different means.
  • the device 400 (partly shown) comprises a housing in which a flexible, relatively soft cannula 451 (inlet not shown) (which e.g.
  • the device further comprises an actuation member 430 slidingly received in the housing of the device, the actuation element being moveable corresponding to a longitudinal direction in parallel with a lower base plate portion 420 comprising an opening 423 for the cannula, the actuation member comprising a release member 431.
  • a first spring 454 is arranged just as a second 464 spring is attached between the actuation member and the needle carrier.
  • the housing is provided with a deflecting structure 425 for deflecting the cannula/insertion needle downwardly during insertion and for holding the cannula in that position, and a releasable catch member 455 holding the cannula carrier in its initial position against a slight biasing force of the first spring, the needle carrier being held in place against the cannula carrier by means of a slight biasing force of the second spring, the distal end of the insertion needle thereby extending from the distal opening of the cannula as shown in fig. 10A .
  • the two springs When a user actuates the actuation member the two springs are compressed corresponding to an intermediate state, however, as the actuation member reaches its fully actuated position the release member 431 releases the catch 455 (see fig. 10B ) which allows the two compressed springs to expand and thereby move the cannula and the insertion needle to their respective extended and downwardly deflected positions whereby the locking catch 456 engages a corresponding catch 421 in the housing as shown in fig. 10C .
  • the first spring expands to bias the actuation member towards its initial position, however, the second spring is shorter than the first spring such that it will withdraw the needle 461 from the cannula when the actuation member is released as shown in fig. 10D .
  • the relative dimensions of the different structures have been chosen for illustrative purposes only, especially, for a working embodiment the outer inner diameter of the cannula will correspond to the outer diameter of the insertion needle with only the minimum necessary clearance therebetween, this in order to provide a cannula with a small outer diameter.
  • a medical device comprising a reservoir, however, for better illustrating the principles of the present invention, the means for expelling a drug from the reservoir has been omitted in the figures.
  • expelling means which as the reservoir does not form part of the present invention in its basic form, may be of any type which would be suitable for arrangement within a skin-mountable drug delivery device.
  • the needle of the present invention also may be in the form of a needle sensor, the interior of the medical device may comprise sensor means adapted to cooperate with the needle sensor.
  • fig. 8A shows a pump arrangement comprising a drug-containing cartridge 1010 having a distal closure member 1011 allowing a needle to be connected, and a piston 1015 slidingly arranged there within, a flexible toothed piston rod 1020 (for example as disclosed in US patent 6,302,869 ), an electric motor 1030 which via a worm-gear arrangement 1031 drives the piston rod to expel drug from the cartridge, the motor being controlled by control means 1040 and the energy for the control means and the motor being provided by a battery 1050.
  • the pump may be activated when the needle is inserted (by means not shown) or by separate user-actuatable means (not shown) after the inserter has been detached form the delivery device.
  • Fig. 8B shows a pump arrangement comprising a drug-containing cartridge 1110 having distal and proximal closure members 1111, 1112, and a piston 1115 slidingly arranged there within, gas generating means 1120 in fluid communication with the interior of the cartridge via conduit 1121 for driving the piston to expel drug from the cartridge, the gas generating means being controlled by control means 1140 and the energy for the control means and the gas generation being provided by a battery 1150.
  • the pump may be activated as indicated above.
  • a detailed disclosure of such gas generating means for a drug delivery device can be found in e.g. US patent 5,858,001 .
  • Fig. 8C shows a pump arrangement comprising a drug-containing cartridge 1210 having distal and proximal closure members 1211, 1212, and a piston slidingly 1215 arranged there within, an osmotic engine 1220 in fluid communication with the interior of the cartridge via conduit 1221 for driving the piston to expel drug from the cartridge.
  • the osmotic engine comprises a first rigid reservoir 1225 containing a salt-solution and a second collapsible reservoir 1226 containing water, the two reservoirs being separated by a semi-permeable membrane 1227.
  • the fluid connection 1228 between the second reservoir and the membrane is closed by a user-severable membrane (e.g.
  • Fig. 8D shows a pump arrangement comprising a drug-containing flexible reservoir 1310 arranged within a rigid fluid-filled secondary reservoir 1311 in fluid communication with a primary reservoir 1320 through a conduit 1330 comprising a flow restrictor 1331.
  • the primary reservoir is in the form of a cartridge with a moveable piston 1321 and contains a viscous drive fluid.
  • a spring is arranged to act on the piston to drive fluid from the first to the second reservoir thereby expelling drug from the flexible reservoir when the latter is connected to an infusion needle (not shown).
  • the flow rate will be determined by the pressure generated by the spring in the drive fluid, the viscosity of the drive fluid and the flow resistance in the flow restrictor (i.e. bleeding hole principle).
  • the pump may be activated by straining the spring or by releasing a pre-stressed spring, either when the needle is inserted (by means not shown) or by separate user-actuatable means (not shown) after the inserter has been detached form the delivery device.
  • a pre-stressed spring An example of this principle used for drug infusion is known from DE 25 52 446 .
  • the drug reservoir may be pressurized directly to expel the drug via a flow restrictor, e.g. as disclosed in US patent 6,074,369 .

Claims (23)

  1. Medizinische Vorrichtung (100, 400), umfassend:
    - ein Gehäuse (110, 120) mit einer Befestigungsfläche (121), die zur Aufbringung auf die Haut eines Patienten angepasst ist,
    - eine transkutane Vorrichtung mit einem entfernten zugespitzten Endteil (151, 451, 461), das zum Durchstechen der Haut des Patienten angepasst ist,
    - wobei die transkutane Vorrichtung eine erste Position, in welcher der entfernte Endteil in das Gehäuse zurückgezogen ist, und eine zweite Position, in welcher der entfernte Endteil in Bezug auf die Befestigungsfläche vorsteht, aufweist,
    - ein durch einen Anwender betätigbares Antriebsmittel (137, 454, 464), das im Gehäuse angeordnet ist und zum Bewegen der transkutanen Vorrichtung von der ersten Position zur zweiten Position, wenn das Antriebsmittel betätigt wird, angepasst ist, dadurch gekennzeichnet, dass
    - das Antriebsmittel mit der in der ersten Position angeordneten transkutanen Vorrichtung von einem ersten Zustand durch einen Zwischenzustand zu einem zweiten Zustand betätigbar ist,
    - wobei die Betätigung des Antriebsmittels vom ersten zum Zwischenzustand die Aktivierung des Antriebsmittels bewirkt und die Betätigung des Antriebsmittels vom Zwischenzustand zum zweiten Zustand die Freigabe des aktivierten Antriebsmittels bewirkt, wodurch die transkutane Vorrichtung von der ersten Position zur zweiten Position bewegt wird.
  2. Medizinische Vorrichtung nach Anspruch 1, des Weiteren umfassend ein Betätigungsmittel (130, 430), das in Bezug auf das Gehäuse von einer ersten Position durch eine Zwischenposition zu einer zweiten Position bewegbar ist,
    - wobei die Bewegung des Betätigungsmittels von der ersten zur Zwischenposition die Aktivierung des Antriebsmittels bewirkt und die Bewegung des Betätigungsmittels von der Zwischenposition zur zweiten Position die Freigabe des aktivierten Antriebsmittels bewirkt, wodurch die transkutane Vorrichtung von der ersten Position zur zweiten Position bewegt wird, wobei das Betätigungsmittel vorzugsweise im Wesentlichen parallel zur Befestigungsfläche bewegbar ist.
  3. Medizinische Vorrichtung nach Anspruch 1 oder 2, wobei das Antriebsmittel ein Federmittel (137, 454, 464) umfasst, das zum freigebbaren Speichern von Energie angepasst ist, und das aktiviert bzw. freigegeben wird, wenn das Antriebsmittel vom ersten Zustand durch den Zwischenzustand zum zweiten Zustand betätigt wird.
  4. Medizinische Vorrichtung nach Anspruch 3,
    - wobei die transkutane Vorrichtung einen Eingriffsteil (257) umfasst oder damit verbunden ist,
    - wobei das Federmittel (237) einen Antriebsteil umfasst, der zum Eingreifen in den Eingriffsteil, wenn das Federmittel freigegeben wird, angepasst ist, und
    - wobei die Aktivierung des Federmittels ein Aktivierungsmoment des Antriebsteils, das der Bewegung, durch welche Energie im Federmittel abgebbar gespeichert ist, entspricht, und eine Verschiebungsbewegung, die sich von der Aktivierungsbewegung unterscheidet, in welcher der Antriebsteil und der Eingriffsteil in Bezug zueinander bewegt werden, bewirkt.
  5. Medizinische Vorrichtung nach Anspruch 4, wobei der Antriebsteil, der dem ersten Zustand entspricht in Bezug auf die Befestigungsfläche unter und neben dem Eingriffsteil angeordnet ist, und wobei der Antriebsteil, der dem Zwischenzustand entspricht in einer oberen Position über dem Eingriffsteil angeordnet ist, wobei die Freigabe des Federmittels eine Abwärtsbewegung des Antriebsteils bewirkt, um in den Eingriffsteil einzugreifen und dadurch die transkutane Vorrichtung von der ersten Position zur zweiten Position bewegt.
  6. Medizinische Vorrichtung nach einem der Ansprüche 3-5, wobei das Federmittel an das Betätigungsmittel gekoppelt ist, die Verschiebungsbewegung des Antriebsteils im Wesentlichen der Bewegung des Betätigungsmittels von der ersten zur Zwischenposition entspricht.
  7. Medizinische Vorrichtung nach Anspruch 6, des Weiteren umfassend ein Rampenmittel (147), das zum Eingreifen in das Federmittel angepasst ist, wodurch eine Bewegung des Betätigungsmittels von der ersten zur Zwischenposition bewirkt, dass das Rampenmittel den Antriebsteil zu seiner oberen Position bewegt und eine Bewegung des Betätigungsmittels von der Zwischenposition zur zweiten Position bewirkt, dass das Rampenmittel außer Eingriff kommt und dadurch das Federmittel freigibt.
  8. Medizinische Vorrichtung nach Anspruch 7, wobei das Federmittel ein Federelement (137) umfasst, das ein an dem Betätigungsmittel befestigtes nahes Ende und einen den Antriebsteil umfassenden entfernten ablenkbaren Endteil aufweist, wobei der entfernte Endteil in das Rampenmittel eingreift.
  9. Medizinische Vorrichtung nach Anspruch 7, wobei das Federelement in Form einer Blattfeder (137) oder eines Strangs (237) vorliegt.
  10. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei die transkutane Vorrichtung ein Trägermittel (153, 154, 353, 363, 453, 463) umfasst, wobei das Trägermittel an das Gehäuse zur gesteuerten Bewegung der transkutanen Vorrichtung zwischen der ersten und zweiten Position gekoppelt ist.
  11. Medizinische Vorrichtung nach Anspruch 10, wobei das Trägermittel (153, 154) drehbar mit dem Gehäuse verbunden ist.
  12. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei die transkutane Vorrichtung eine hohle Infusionsnadel ist, umfassend ein nahes Ende (152) und den entfernten zugespitzten Endteil (151).
  13. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei die transkutane Vorrichtung eine Kanüle (351, 451) in Kombination mit einer zugespitzten Einführnadel (361, 461) ist, die zumindest teilweise in der Kanüle untergebracht ist, wobei die Kanüle eine entfernte Öffnung aufweist,
    - wobei die Kanüle und die Einführnadel so angeordnet sind, dass sie durch das Antriebsmittel gleichzeitig von ihrer jeweiligen ersten Position zu ihrer jeweiligen zweiten Position bewegt werden, wenn das Antriebsmittel betätigt wird,
    - wobei die Einführnadel so angeordnet ist, dass sie von der entfernten Öffnung weg bewegbar ist, wenn die Kanüle und die Einführnadel zu ihrer zweiten Position bewegt wurden.
  14. Medizinische Vorrichtung nach Anspruch 13, wobei die Kanüle ein von einer Nadel durchstechbares Septum (352, 452) umfasst, durch welches die Einführnadel angeordnet ist, wenn die Kanüle und die Einführnadel von ihrer jeweiligen ersten Position zu ihrer jeweiligen zweiten Position bewegt werden.
  15. Medizinische Vorrichtung nach einem der Ansprüche 12-14, des Weiteren umfassend:
    - einen Behälter (160) der angepasst ist, um ein flüssiges Arzneimittel zu enthalten und der in einer Verwendungssituation einen Auslass (161) in Fluidkommunikation mit der Infusionsnadel umfasst, und
    - ein Ausstoßmittel zum Ausstoßen eines Arzneimittels aus dem Behälter und durch die Haut des Patienten über die hohle Nadel.
  16. Medizinische Vorrichtung nach Anspruch 15, wenn abhängig von Anspruch 2, wobei der Behälter mit dem Betätigungsmittel verbunden ist, wodurch die Bewegung des Betätigungsmittels zwischen der erste und der zweiten Position bewirkt, dass der Behälter in Fluidkommunikation mit der Infusionsnadel angeordnet ist.
  17. Medizinische Vorrichtung nach Anspruch 15 oder 16, wobei eine Bewegung des Betätigungsmittels zwischen der ersten und der zweiten Position die Betätigung des Ausstoßmittels bewirkt.
  18. Medizinische Vorrichtung nach einem der Ansprüche 1-11, wobei die transkutane Vorrichtung eine längliche Sensorvorrichtung in Kombination mit einer zugespitzten Einführnadel ist, die angeordnet ist, um einen entfernten Teil der Sensorvorrichtung zu tragen,
    - wobei die Sensorvorrichtung und die Einführnadel angeordnet sind, um gleichzeitig durch das Antriebsmittel von ihrer jeweiligen ersten Position zu ihrer jeweiligen zweiten Position bewegt zu werden, wenn das Antriebsmittel betätigt wird,
    - wobei die Einführnadel angeordnet ist, um von dem entfernten Teil weg bewegbar zu sein, wenn die Sensorvorrichtung und die Einführnadel zu ihrer zweiten Position bewegt werden.
  19. Medizinische Vorrichtung nach einem der Ansprüche 16-18, umfassend ein Federmittel zum automatischen Entnehmen der Einführnadel, wenn die kombinierte transkutane Vorrichtung zur zweiten Position vorwärts bewegt wurde.
  20. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei das Antriebsmittel im zweiten Zustand eine Kraft auf mindestens einen Teil der transkutanen Vorrichtung ausübt, wodurch es gegen die zweite Position vorgespannt wird.
  21. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei sich der entfernte Endteil im Allgemeinen rechtwinklig zur Befestigungsfläche erstreckt.
  22. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei die Befestigungsfläche eine darin gebildete Öffnung umfasst, wobei der entfernte Endteil der transkutanen Vorrichtung durch die Öffnung bewegt wird, wenn die transkutane Vorrichtung von der ersten zur zweiten Position bewegt wird.
  23. Medizinische Vorrichtung nach einem der vorangehenden Ansprüche, wobei die Befestigungsfläche ein Klebemittel (121) zum Anhaften der medizinischen Vorrichtung an die Haut des Patienten umfasst.
EP04731882A 2003-05-08 2004-05-10 Interne nadeleinführvorrichtung Revoked EP1624914B1 (de)

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DKPA200300697 2003-05-08
US47101003P 2003-05-16 2003-05-16
PCT/DK2004/000333 WO2004098683A1 (en) 2003-05-08 2004-05-10 Internal needle inserter

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EP1624914B1 true EP1624914B1 (de) 2008-04-16

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AT (1) ATE392223T1 (de)
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DE602004013140D1 (de) 2008-05-29
DE602004013140T2 (de) 2009-07-02
US20060142698A1 (en) 2006-06-29
EP1624914A1 (de) 2006-02-15
US7981085B2 (en) 2011-07-19
WO2004098683A1 (en) 2004-11-18
ATE392223T1 (de) 2008-05-15

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